Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02720536
Recruitment Status : Completed
First Posted : March 28, 2016
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Extend evaluation of deferasirox film-coated tablet (FCT) formulation

Condition or disease Intervention/treatment Phase
Chronic Iron Overload Drug: Deferasirox Phase 3

Detailed Description:

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201

  • Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.
  • Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.
  • Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201
Actual Study Start Date : August 16, 2016
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : July 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
Drug Information available for: Deferasirox

Arm Intervention/treatment
Experimental: Deferasirox
Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
Drug: Deferasirox
Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.




Primary Outcome Measures :
  1. Overview of Number of Participants With Adverse Events [ Time Frame: Baseline up to approximately 25 months ]
    Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study

  2. Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  3. Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  4. Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  5. Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  6. Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  7. Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

  8. Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline


Secondary Outcome Measures :
  1. Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12 [ Time Frame: Baseline, 6 and 12 months ]
    The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study

  2. Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12 [ Time Frame: Baseline, 6 and 12 months ]
    The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × ([Post - Baseline] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria for subjects:

  • Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).
  • Were deemed to have tolerated deferasirox treatment by the investigator.
  • Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.

Key Exclusion for subjects:

The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:

  • Creatinine clearance below the contraindication limit in the locally approved prescribing information.
  • Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening
  • Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,
  • Significant proteinuria
  • Patients with significant impaired gastrointestinal function or gastrointestinal disease
  • Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
  • Patients with psychiatric or addictive disorders
  • Patients with a known history of HIV seropositivity (Elisa or Western blot).
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
  • Patients with a history of hypersensitivity to any of the study drug or excipients.
  • Patients with significant medical condition that could interfere with the ability to participate in this study
  • Patients who were participating in another clinical trial or receiving an investigational drug.
  • Patients using prohibited medication,
  • Patients with liver disease with severity of Child-Pugh Class B or C.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720536


Locations
Layout table for location information
Austria
Novartis Investigative Site
Vienna, Austria, 1140
Greece
Novartis Investigative Site
Goudi-Athens, GR, Greece, 115 27
Novartis Investigative Site
Patras, Greece, 265 00
Novartis Investigative Site
Thessaloniki, Greece, 54642
Italy
Novartis Investigative Site
Catania, CT, Italy, 95125
Novartis Investigative Site
Cona, FE, Italy, 44100
Novartis Investigative Site
Genova, GE, Italy, 16128
Novartis Investigative Site
Cagliari, ITA, Italy, 09121
Novartis Investigative Site
Lecce, LE, Italy, 73100
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Palermo, PA, Italy, 90127
Novartis Investigative Site
Palermo, PA, Italy, 90146
Novartis Investigative Site
Verona, VR, Italy, 37126
Novartis Investigative Site
Napoli, Italy, 80138
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] August 26, 2019
Study Protocol  [PDF] October 25, 2017


Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02720536    
Other Study ID Numbers: CICL670AIC04
First Posted: March 28, 2016    Key Record Dates
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
adult
pediatric,
anemia.
Myelodysplastic Syndrome
Thalassemia
Film coated tablet
ICL670
MDS
Chelation
Deferasirox
Iron overload
Additional relevant MeSH terms:
Layout table for MeSH terms
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action